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Abstract Details

Exploratory Study of Acoustic Neuromodulation Improves Caregiver Burden, Insomnia, Stress, Anxiety, and Autonomic Function
Sleep
Sleep Posters (7:00 AM-5:00 PM)
002
Caregiver burden and burnout is a public health crisis.  Literature reports higher levels of stress, anxiety, insomnia, depression, and other mental health effects in caregivers.  Effective non-drug, noninvasive, cost-effective, durable modalities are lacking.  CR is a noninvasive, closed-loop, acoustic neuromodulation technology, echoing brainwaves in real time as auditory tones. 
Evaluate the impact of Cereset Research™ (CR), on caregiver burden, insomnia, stress, anxiety and autonomic function.
12 caregivers (median age 57, 6 years caregiving, 10 female) with insomnia (ISI, ≥8 points for ≥1 month), stress (PSS ≥14), anxiety (GAD-7 ≥5), were enrolled in an open-label, exploratory trial.  Subjects received 6-12, sixty-minute sessions of tones linked to brainwaves plus continued current care.  Data was collected at baseline (V1), 0-21 days (V2) after intervention, 4-7 weeks after V2 (V3), and 4-7 weeks after V3 (V4).  10-minute BP and HR recordings using a continuous non-invasive blood pressure system, allowed analysis of HRV (SDNN and rMSSD), as primary outcome, with change in ISI, PSS, GAD-7, CES-D, PCL-C, ZBI, and CSAQ as secondary.  We report interim results for symptom and HRV outcomes across visits.
11 subjects completed V1-V3 measures (1 dropout).  Median changes from V1 to V3, ISI score: -6 (p=0.013); PSS score: -4 (p=0.039); GAD-7: -6 (p=0.001), CES-D: -10 (p=0.014); PCL-C: -13 (p=0.002); ZBI: -5 (p=0.166); and CSAQ: -2 (p=0.053).  Significant symptom reductions were durable to V4, with trends for ZBI, and CSAQ.  Mean SDNN and rMSSD significantly increased 101% (SE=45.7) and 175% (84.3) from V1 to V2 and tended to increase from V1 to V3.
Interim results suggest significant, clinically meaningful reductions for self-reported symptom scores for insomnia, anxiety, depression, and post-traumatic stress, with trends for reduced burden, and improved autonomic function measures for caregivers after using this innovative non-drug intervention.  Further evaluation is warranted.
Authors/Disclosures
Charles H. Tegeler, MD (Wake Forest School of Medicine)
PRESENTER
Dr. Tegeler has nothing to disclose.
Catherine Tegeler (Wake Forest Sch of Med, Neurology) Ms. Tegeler has nothing to disclose.
Lindsay J. Howard (Wake Forest Baptist Health) Ms. Howard has nothing to disclose.
Kenzie Brown No disclosure on file
Dawn Kellar No disclosure on file
No disclosure on file
No disclosure on file
Hossam A. Shaltout, PhD (Wake Forest School of Medicine) Dr. Shaltout has nothing to disclose.